Your Quality Management Data Template
Your Quality Management Data Template
- Recommended attributes to collect
- Key activities to track
- Extraction guidance
Quality Management Attributes
| Name | Description | ||
|---|---|---|---|
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Quality Event
QualityEvent
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The unique identifier for a single quality event, such as a deviation, non-conformance, or CAPA. | ||
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Description
The Quality Event serves as the primary case identifier, linking all activities, investigations, and resolutions related to a specific quality issue. It acts as the central thread that connects the entire lifecycle of an incident from its initial report to its final closure. In process mining, this attribute is crucial for reconstructing the end-to-end journey of each quality event. It allows for the analysis of process variations, cycle times, and compliance across different types of events, providing a comprehensive view of how individual quality incidents are managed, investigated, and resolved.
Why it matters
This is the essential Case ID that groups all related activities into a single process instance, making end-to-end analysis possible.
Where to get
This is the primary identifier for Quality Event records in Veeva Vault Quality, often referred to as 'Name' or a unique ID field on the Quality Event object.
Examples
QE-2023-00123CAPA-2023-00456DEV-2023-00789
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Activity Name
ActivityName
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The name of a specific task or step that occurred within the quality event lifecycle. | ||
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Description
This attribute describes a distinct business activity or event that happens during the management of a quality event. These are the steps in the process, such as 'Investigation Initiated' or 'Corrective Action Plan Approved'. Analyzing the sequence and frequency of these activities is the core of process mining. It helps discover the actual process flow, identify bottlenecks between steps, and detect deviations from the standard operating procedure.
Why it matters
It defines the steps of the process, enabling the visualization and analysis of the process flow.
Where to get
This is typically derived from workflow task names, status changes, or audit trail entries within Veeva Vault Quality.
Examples
Initial Triage CompletedRoot Cause Analysis PerformedFinal Review And Closure
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Event Time
EventTime
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The timestamp indicating when a specific activity started or occurred. | ||
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Description
This attribute captures the precise date and time that an activity was executed. It provides the chronological context for all events within a case. This timestamp is fundamental for all time-based process mining analyses. It is used to calculate cycle times, waiting times between activities, and durations of specific steps, which are essential for identifying delays and performance bottlenecks.
Why it matters
This timestamp is critical for ordering events chronologically and calculating all performance metrics like cycle time and waiting time.
Where to get
This corresponds to the creation date or completion date of tasks, or the timestamp of events in the audit trail of a Quality Event object.
Examples
2023-10-26T10:00:00Z2023-11-01T14:35:10Z2023-11-15T09:21:05Z
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Last Data Update
LastDataUpdate
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The timestamp of the last data refresh or extraction from the source system. | ||
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Description
This attribute indicates the freshness of the data being analyzed. It shows the date and time when the data was last extracted from Veeva Vault Quality and loaded into the process mining tool. This information is critical for users to understand the timeliness of the analysis and to know if the dashboards reflect the most current state of operations. It is a key data governance attribute.
Why it matters
Informs users about the timeliness and relevance of the data, ensuring they understand how current the process analysis is.
Where to get
This timestamp is generated and added during the data extraction, transformation, and loading (ETL) process.
Examples
2024-05-20T08:00:00Z2024-05-21T08:00:00Z
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Source System
SourceSystem
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The system from which the quality management data was extracted. | ||
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Description
This attribute identifies the origin of the data, which in this case is Veeva Vault Quality. It helps in data governance and provides context, especially when data from multiple systems is combined. In analysis, it's used for filtering and ensuring data lineage. Understanding the source system helps in interpreting the data correctly and troubleshooting any data quality issues.
Why it matters
Provides essential context about data origin, which is crucial for data governance, traceability, and multi-system analysis.
Where to get
This is a static value that should be added during the data transformation process to label all records from this source.
Examples
Veeva Vault Quality
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Activity Duration
ActivityDuration
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The processing time for a single activity. | ||
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Description
This metric measures the time spent actively working on a task. It is calculated as the difference between the EndTime and StartTime of an activity. Analyzing activity duration helps pinpoint which specific steps in the process are most time-consuming. This differs from waiting time, as it reflects the actual work effort. It is a key metric for identifying inefficiencies within individual tasks and for resource capacity planning.
Why it matters
Measures the actual work time for tasks, helping to identify inefficient activities and opportunities for automation or simplification.
Where to get
This is a calculated metric, derived by subtracting the 'EventTime' (StartTime) from the 'EndTime' for each activity.
Examples
2 hours 30 minutes45 minutes8 hours 15 minutes
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Assigned Department
AssignedDepartment
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The department or functional area responsible for the quality event or activity. | ||
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Description
This attribute specifies the business unit or department, such as Quality Assurance, Manufacturing, or R&D, that is responsible for handling the quality event or a particular task. This is often derived from the assigned user's profile. This dimension is critical for high-level performance analysis. It allows for comparing process efficiency and compliance across different parts of the organization, helping to pinpoint systemic issues within specific departments and supporting the 'Investigator Workload Distribution' dashboard.
Why it matters
Allows for filtering and comparing process performance across different business units, revealing departmental bottlenecks or best practices.
Where to get
This information is typically stored in user profile data linked to the 'Assigned Investigator' or can be a direct field on the Quality Event object itself.
Examples
Quality AssuranceManufacturing OperationsResearch & Development
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Assigned Investigator
AssignedInvestigator
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The user or resource assigned to perform an investigation or a specific task. | ||
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Description
This attribute identifies the person, role, or team responsible for executing a given activity within the quality event lifecycle. It can be the owner of the quality event itself or the assignee of a specific workflow task. Analyzing this attribute helps in understanding workload distribution, resource performance, and identifying overburdened teams or individuals. It is essential for the 'Investigator Workload Distribution' dashboard and for optimizing resource allocation to improve efficiency.
Why it matters
Tracks who performs the work, enabling analysis of workload, resource efficiency, and identification of training needs.
Where to get
Found in the owner or assigned user fields on the Quality Event object or its related workflow task objects in Veeva Vault Quality.
Examples
Alice JohnsonBob WilliamsQA Investigation Team
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End Time
EndTime
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The timestamp indicating when an activity was completed. | ||
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Description
This attribute captures the date and time that a specific activity or task concluded. It is distinct from the StartTime (EventTime) and is essential for understanding the duration of individual steps in the process. In process mining, the EndTime is used in conjunction with the StartTime to calculate the processing time of activities. This is fundamental for identifying which specific tasks are taking the longest, contributing to overall cycle time and potential delays.
Why it matters
Enables the calculation of activity processing times, which is crucial for identifying bottlenecks at the task level.
Where to get
This timestamp is typically available in the workflow history or audit trail data for a Quality Event, often as a 'completed date' or 'modified on' field for a specific task or status.
Examples
2023-10-26T11:30:00Z2023-11-01T18:00:10Z2023-11-15T09:45:00Z
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Quality Event Status
QualityEventStatus
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The current lifecycle state of the quality event. | ||
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Description
This attribute indicates the current status of the quality event, such as 'Open', 'In Investigation', 'Pending Approval', or 'Closed'. It provides a snapshot of where each case is in its lifecycle. This is essential for the 'Quality Event Progress Overview' dashboard, enabling real-time monitoring of ongoing cases. It helps managers track progress, identify stalled events, and manage the overall workload effectively.
Why it matters
Provides a snapshot of the current state of a case, which is essential for monitoring ongoing work and identifying stalled events.
Where to get
This is a standard field on the Quality Event object in Veeva Vault Quality that reflects its position in the lifecycle.
Examples
In TriageIn InvestigationCAPA ProposedClosed
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Quality Event Type
QualityEventType
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The classification of the quality event, such as CAPA, Deviation, or Complaint. | ||
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Description
This attribute categorizes the quality event based on its nature. Different types of quality events often follow different process paths and have different compliance requirements and resolution timelines. Analyzing by event type is fundamental to understanding process variations. It allows for comparing the performance and efficiency of handling deviations versus CAPAs, for example, and helps tailor improvement initiatives to specific process contexts.
Why it matters
Distinguishes between different kinds of quality processes, which often have unique workflows, SLAs, and compliance rules.
Where to get
This is a standard classification field on the Quality Event object in Veeva Vault Quality, often a picklist.
Examples
DeviationCorrective and Preventive Action (CAPA)Non-conformanceComplaint
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Severity Level
SeverityLevel
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The assessed severity or risk level of the quality event, such as high, medium, or low. | ||
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Description
This attribute classifies the quality event based on its potential impact on product quality, patient safety, or regulatory compliance. The severity often dictates the urgency and required depth of the investigation. Analyzing by severity level is key to prioritizing improvement efforts. It helps understand if high-severity events take longer to resolve, follow different process paths, or have a higher rework rate, ensuring that the most critical issues receive the most attention.
Why it matters
Classifies events by impact, allowing for risk-based analysis and prioritization of process improvement efforts on high-risk areas.
Where to get
This is a standard classification field on the Quality Event object, often a picklist derived from a risk matrix.
Examples
HighMediumLow
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Target Resolution Date
TargetResolutionDate
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The planned or required date for the final closure of the quality event. | ||
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Description
This attribute defines the service level agreement (SLA) or target deadline for resolving a quality event. It is often calculated based on the event's creation date and its severity or type. This date is the benchmark against which actual performance is measured. It is critical for the 'On-Time Resolution Performance' dashboard and the 'On-Time Resolution Rate' KPI, helping to identify whether events are being resolved in a timely manner and what factors contribute to delays.
Why it matters
Defines the SLA for case resolution, enabling the measurement of on-time performance and the analysis of delays.
Where to get
This is likely a date field on the Quality Event object, which may be manually entered or automatically calculated by the system.
Examples
2024-01-15T23:59:59Z2024-02-28T23:59:59Z2024-03-10T23:59:59Z
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Approval Time
ApprovalTime
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The time taken for a specific approval activity to be completed. | ||
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Description
This metric measures the duration of approval steps, such as 'Corrective Action Plan Approved'. It is calculated as the time from when an approval is requested to when it is granted or rejected. This attribute is specifically designed to support the 'Approval Workflow Bottlenecks' dashboard and the 'Approval Workflow Cycle Time' KPI. By isolating the time spent waiting for approvals, it helps identify and address delays caused by slow decision-making or inefficient approval processes.
Why it matters
Pinpoints delays in critical decision-making steps, helping to streamline approval workflows and reduce overall cycle time.
Where to get
This metric is calculated by finding the time difference between the start and end of approval-related activities in the event log.
Examples
3 days 4 hours1 day 0 hours7 days 8 hours
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Cycle Time
CycleTime
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The total time elapsed from the creation of a quality event to its final closure. | ||
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Description
This metric represents the end-to-end duration for resolving a quality event. It is calculated as the time difference between the very first activity (e.g., 'Quality Event Created') and the very last activity (e.g., 'Final Review and Closure'). Cycle time is a primary key performance indicator for overall process efficiency. It is used in the 'Quality Event Resolution Time' dashboard to analyze trends, identify factors that lead to long resolution times, and set benchmarks for process improvement.
Why it matters
Measures end-to-end process efficiency, providing a critical KPI to track overall performance and the impact of improvement initiatives.
Where to get
This is a calculated metric. It is computed at the case level by subtracting the timestamp of the first event from the timestamp of the last event.
Examples
30 days 12 hours65 days 4 hours15 days 2 hours
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Effectiveness Check Result
EffectivenessCheckResult
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The outcome of the verification step to confirm if a corrective action was effective. | ||
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Description
This attribute records the result of the effectiveness check, which is performed after a corrective action has been implemented. The outcome is typically 'Effective' or 'Not Effective'. This is a direct measure of the success of the CAPA process and is crucial for the 'CAPA Effectiveness & Recurrence Rate' dashboard and the 'CAPA Effectiveness Rate' KPI. It provides clear feedback on whether the implemented solutions are actually preventing the problem from happening again.
Why it matters
Directly measures the success of corrective actions, providing critical feedback for improving the problem-solving process.
Where to get
This would be a field, likely a picklist, on a CAPA Action or Effectiveness Check object related to the primary Quality Event.
Examples
EffectiveNot EffectivePending Verification
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Is On Time Resolution
IsOnTimeResolution
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A calculated flag indicating if the quality event was closed by its target date. | ||
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Description
This boolean attribute is derived by comparing the actual closure date of a quality event with its 'Target Resolution Date'. It provides a simple, binary outcome for on-time performance. This flag is the foundation for the 'On-Time Resolution Performance' dashboard and the 'On-Time Resolution Rate' KPI. It allows for easy aggregation and filtering to understand what types of events, departments, or sites struggle to meet deadlines.
Why it matters
Provides a clear success or failure metric for meeting deadlines, simplifying performance analysis and reporting.
Where to get
Calculated by comparing the timestamp of the 'Final Review and Closure' activity with the 'TargetResolutionDate' attribute. Formula: Closure Time <= TargetResolutionDate.
Examples
truefalse
|
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Is Recurrence
IsRecurrence
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A flag indicating whether this quality event is a recurrence of a previously identified issue. | ||
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Description
This boolean attribute signals that a quality event is not a new, unique issue but a repeat of a problem that has occurred before. This is a critical indicator of the failure of previous corrective actions. This flag is fundamental to the 'CAPA Effectiveness & Recurrence Rate' dashboard. Tracking recurrences provides direct feedback on the long-term success of the quality management system and helps identify systemic problems that are not being adequately addressed.
Why it matters
Highlights failures in corrective actions, enabling analysis of why problems are repeating and how to improve long-term solutions.
Where to get
This could be a checkbox field on the Quality Event object or a derived field based on links to previous, similar events.
Examples
truefalse
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Is Rework
IsRework
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A calculated flag that identifies activities or cases that represent rework. | ||
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Description
This attribute is a boolean flag indicating that a particular activity or sequence of activities represents rework, such as repeating an investigation or re-opening a closed CAPA. It is not a standard field but is calculated based on process flow patterns. In process mining, this flag is used to quantify the amount of wasted effort and cost in the process. It is essential for the 'Rework Analysis' dashboard and the 'Quality Event Rework Rate' KPI, helping to pinpoint the causes of inefficiency and poor first-time quality.
Why it matters
Quantifies process inefficiency by flagging repeated work, which helps identify the root causes of quality issues and wasted effort.
Where to get
This attribute is not sourced directly. It is calculated during data transformation by detecting repeated activity names or loops in the process for a given case.
Examples
truefalse
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Product
Product
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The product or material associated with the quality event. | ||
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Description
This attribute links the quality event to a specific product, material, or batch. This connection is vital in regulated industries for traceability and impact analysis. Analyzing quality events by product helps identify if certain products are more prone to issues, guiding product improvement or manufacturing process adjustments. It allows for filtering dashboards to see performance for specific product lines.
Why it matters
Links quality events to specific products, enabling analysis to identify product-specific issues and trends.
Where to get
This is typically a reference field on the Quality Event object that links to a Product or Material object in Veeva Vault.
Examples
Product A-100Product B-200Raw Material C-300
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Root Cause
RootCause
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The identified underlying cause of the quality event. | ||
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Description
This attribute contains the final conclusion of the root cause analysis (RCA) investigation. It categorizes the fundamental reason for the quality issue, such as equipment failure, human error, or procedural deficiency. Analyzing root causes is essential for effective problem-solving. It helps identify recurring systemic issues that need to be addressed through corrective and preventive actions. This attribute directly supports the 'Root Cause Analysis Cycle Time' and 'CAPA Effectiveness' dashboards.
Why it matters
Categorizes the fundamental reasons for quality issues, enabling strategic analysis to prevent future recurrence.
Where to get
This is typically a text field or a picklist on the Quality Event object or a related Root Cause Analysis object.
Examples
Equipment MalfunctionProcedural ErrorInadequate TrainingMaterial Defect
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Site
Site
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The manufacturing site, plant, or location where the quality event occurred or was identified. | ||
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Description
This attribute specifies the physical location, such as a manufacturing plant or laboratory, associated with the quality event. It provides a geographical or organizational context for the issue. This is a powerful dimension for comparative analysis, allowing management to compare process performance, issue types, and resolution times across different sites. It can help identify site-specific problems or share best practices from high-performing locations.
Why it matters
Provides a geographical or organizational dimension for analysis, helping to compare performance and identify site-specific issues.
Where to get
This is often a standard field on the Quality Event object, linking to a list of company sites or locations.
Examples
Site A - New JerseySite B - IrelandSite C - Switzerland
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Quality Management Activities
| Activity | Description | ||
|---|---|---|---|
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Corrective Action Implemented
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Represents the completion of all tasks defined in the approved corrective action plan. This activity confirms that the necessary actions have been taken to address the root cause. This is captured when the CAPA record's status is updated to 'Implementation Complete'. | ||
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Why it matters
This is a major milestone that signifies the transition from planning to execution. The time between this and CAPA approval reveals the efficiency of the implementation phase.
Where to get
Inferred from a lifecycle state change on the associated CAPA object to a status like 'Implemented' or 'Pending Effectiveness Check'.
Capture
From the state change timestamp on the linked CAPA object.
Event type
inferred
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Corrective Action Plan Approved
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Marks the formal approval of the proposed corrective action plan by relevant stakeholders, such as a quality review board. This is a critical gateway before any corrective actions can be implemented. It is captured when the CAPA plan record moves to an 'Approved' state. | ||
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Why it matters
This approval step is often a major bottleneck. Measuring the 'Approval Workflow Cycle Time' for this activity helps identify and address delays in the review process, accelerating overall resolution.
Where to get
Inferred from the timestamp of a lifecycle state change to 'Approved' on the associated CAPA Plan object. This event may be mirrored as a state change on the parent Quality Event.
Capture
From the state change timestamp on the linked CAPA Plan object.
Event type
inferred
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Effectiveness Of Action Verified
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This activity confirms that the implemented corrective actions were successful in preventing a recurrence of the issue. A formal verification is completed and documented. It is captured when the CAPA or Quality Event status is updated to 'Effectiveness Verified'. | ||
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Why it matters
This is the final validation of the solution's success and is critical for calculating the 'CAPA Effectiveness Rate'. A failure at this stage often leads to rework, re-opening the investigation.
Where to get
Inferred from a lifecycle state change on the Quality Event or CAPA object to a status such as 'Verified' or 'Closed - Effective'.
Capture
From state change timestamp indicating successful verification.
Event type
inferred
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Final Review And Closure
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Represents the last administrative review of the Quality Event record before it is officially closed. This step ensures all documentation is complete and all process steps were followed. This activity is the final step before the case is considered resolved. | ||
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Why it matters
This end activity is essential for calculating the total 'Quality Event Cycle Time'. It signifies the completion of all work, and its timestamp is compared against the 'Target Resolution Date' for performance measurement.
Where to get
Inferred from a lifecycle state change on the Quality Event object to 'Closed', 'Resolved', or a similar terminal state.
Capture
From the timestamp of the final state change to 'Closed'.
Event type
inferred
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Investigation Initiated
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Marks the formal start of the investigation into the quality event's root cause. An investigator or team is typically assigned, and the event moves into an active investigative phase. This is captured when the Quality Event's lifecycle state changes to 'Under Investigation'. | ||
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Why it matters
This is a key milestone for measuring the 'Issue Identification-to-Investigation Time' KPI. Delays before this point indicate backlogs in assigning resources or starting critical analysis.
Where to get
Inferred from the timestamp when the Quality Event object's lifecycle state is updated to 'Under Investigation' or a similar status. The assignment of an investigator can also serve as a trigger.
Capture
Use the timestamp of the state change to 'Under Investigation'.
Event type
inferred
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Quality Event Created
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This is the starting point of the process, representing the formal creation of a Quality Event record in Veeva. This activity is typically triggered when a new quality issue, non-conformance, or complaint is identified and logged into the system. | ||
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Why it matters
This activity marks the beginning of the case lifecycle, making it essential for calculating the total Quality Event Cycle Time and measuring the duration of initial process phases, such as the time to start an investigation.
Where to get
This is an explicit event captured from the creation timestamp of the Quality Event object in Veeva Vault. The audit trail for the object will show the exact creation date, time, and user.
Capture
Use the creation timestamp of the main Quality Event record.
Event type
explicit
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Root Cause Analysis Performed
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Represents the completion of the root cause analysis (RCA) phase, where the underlying cause of the quality event has been identified. This is often logged when the investigator completes the RCA task or moves the event to a 'Pending CAPA' state. | ||
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Why it matters
This activity is crucial for measuring the 'Average Root Cause Analysis Time' KPI. Analyzing its duration helps identify bottlenecks in the analytical process and improve investigation quality.
Where to get
Typically inferred from a lifecycle state change on the Quality Event object, such as moving to 'RCA Complete' or 'Pending Action Plan'. It might also correspond to the completion of a specific workflow task.
Capture
From state change timestamp or completion of an RCA-related task.
Event type
inferred
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Corrective Action Plan Proposed
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This activity occurs when a formal plan to correct the identified root cause is drafted and submitted for review. It often involves creating a related CAPA (Corrective and Preventive Action) record linked to the Quality Event. The event is captured when the CAPA record is created or the Quality Event status is updated. | ||
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Why it matters
Tracking this step helps analyze the time taken to move from analysis to solution design. It's a key input for understanding the 'Root Cause Analysis Cycle Time' from RCA completion to CAPA proposal.
Where to get
This can be inferred from a lifecycle state change on the Quality Event object to 'Pending CAPA Approval', or from the creation timestamp of a linked CAPA Plan record.
Capture
Use creation timestamp of a linked CAPA record or a state change.
Event type
inferred
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Effectiveness Check Initiated
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Marks the beginning of the period where the effectiveness of the implemented corrective actions is monitored. This is not a point-in-time event but rather the start of a verification phase. It is captured when the Quality Event or CAPA record enters a 'Monitoring' or 'Pending Effectiveness Verification' state. | ||
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Why it matters
This activity initiates the final validation loop. The duration of the effectiveness check phase is important for understanding how long it takes to confirm a resolution's success.
Where to get
Inferred from a lifecycle state change on the Quality Event or CAPA object to a status like 'Under Effectiveness Review'.
Capture
From state change timestamp to a monitoring-related state.
Event type
inferred
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Initial Triage Completed
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Represents the completion of the initial review and assessment of the quality event. During this stage, basic information is gathered and verified to determine the event's validity and immediate impact. This is often captured when the record's status changes from 'New' to 'Under Assessment' or a similar state. | ||
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Why it matters
Analyzing the time spent in triage helps identify delays in the initial handling of quality events. It provides insights into workload and resource allocation at the very beginning of the process.
Where to get
Inferred from the timestamp when the Quality Event object's lifecycle state is updated to reflect that triage is complete, for example, moving from 'New' to 'In Assessment' or 'Triaged'.
Capture
From state change timestamp on the Quality Event object.
Event type
inferred
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Issue Categorized And Prioritized
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This activity marks the point where the quality event has been formally categorized by type, severity level, and priority. This is a critical step that determines the subsequent investigation path and timeline. It's typically captured by a status change indicating the completion of this classification. | ||
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Why it matters
This event is crucial for segmenting process analysis by event severity or type. It helps understand if high-priority issues are processed faster than low-priority ones and ensures resources are allocated effectively.
Where to get
Inferred from a lifecycle state change on the Quality Event object, such as moving to a state like 'Categorized' or 'Pending Investigation'. It can also be inferred from the timestamp when key classification fields are populated.
Capture
Inferred from a state change or population of fields like 'Severity' and 'Priority'.
Event type
inferred
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Preventive Action Identified
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This activity occurs when a preventive action is identified to address potential future recurrences, often as a result of the investigation. It is captured by the creation of a Preventive Action (PA) record linked to the quality event. | ||
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Why it matters
While not part of every case, tracking this activity helps understand how proactive the quality process is. It provides insights into the organization's focus on long-term prevention versus immediate correction.
Where to get
Inferred from the creation timestamp of a linked Preventive Action record within Veeva Vault.
Capture
Use creation timestamp of a linked Preventive Action record.
Event type
inferred
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Stakeholders Notified Of Resolution
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This activity represents the communication sent to relevant stakeholders informing them of the quality event's resolution. This might be an automated email notification triggered by the final closure step or a manually logged communication task. | ||
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Why it matters
Timely communication is key to stakeholder satisfaction and transparency. This activity allows for measuring the 'Stakeholder Notification Lag Time' KPI, highlighting delays in communication.
Where to get
This may be an explicit event if Veeva Vault sends automated notifications that are logged. Alternatively, it could be inferred from the completion of a manual 'Notify Stakeholders' workflow task.
Capture
From system notification logs or the completion timestamp of a communication task.
Event type
explicit
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